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Sumec Instruments Equipment Co.,Ltd

✅ Low Risk

FEI: 3006395413 • Nanjing, Jiangsu • CHINA

FEI

FEI Number

3006395413

📍

Location

Nanjing, Jiangsu

🇨🇳

Country

CHINA
🏢

Address

# 198 Changjiang Road, Liuhe, Nanjing, Jiangsu, China

Low Risk

FDA Import Risk Assessment

19.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

2
Total Refusals
1
Unique Violations
12/4/2007
Latest Refusal
9/21/2007
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
How is this score calculated?

Proprietary Algorithm

  • 40% Violation Severity — AI-assessed (1-10)
  • 30% Refusal Volume — Logarithmic scale
  • 20% Recency — Decays over 5 years
  • 10% Frequency — Refusals per year

© ImportRefusal.com Original Analysis

Violation Summary

3412×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

Refusal History

DateProductViolationsDivision
12/4/2007
79HXTTAPE, ORTHOPEDIC
341REGISTERED
Division of Southeast Imports (DSEI)
9/21/2007
87MTTCAST, STOCKING, ANTI-MICROBIALS
341REGISTERED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Sumec Instruments Equipment Co.,Ltd's FDA import refusal history?

Sumec Instruments Equipment Co.,Ltd (FEI: 3006395413) has 2 FDA import refusal record(s) in our database, spanning from 9/21/2007 to 12/4/2007.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Sumec Instruments Equipment Co.,Ltd's FEI number is 3006395413.

What types of violations has Sumec Instruments Equipment Co.,Ltd received?

Sumec Instruments Equipment Co.,Ltd has been cited for 1 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about Sumec Instruments Equipment Co.,Ltd come from?

All FDA import refusal data for Sumec Instruments Equipment Co.,Ltd is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.